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EUS-Guided ATI and SWE in Individuals With Normal FibroScan (EUS ATI&SWE)

2026년 7월 15일 업데이트: Mohan Ramchandani, Asian Institute of Gastroenterology, India

"EUS-Guided Attenuation Imaging and Shear Wave Elastography in Individuals With Normal FibroScan: Establishing Preliminary Reference Values in a Pilot Feasibility Study".

The goal of this observational study is to establish preliminary reference values for Endoscopic Ultrasound (EUS)-guided Attenuation Imaging (ATI) and Shear Wave Elastography (SWE) in adults undergoing diagnostic EUS for non-hepatobiliary indications who have normal FibroScan findings. The main questions it aims to answer are:

What are the preliminary normal reference values for EUS-guided ATI in the right and left hepatic lobes? What are the preliminary normal reference values for EUS-guided SWE elasticity (kPa) and velocity (m/s) in the right and left hepatic lobes?

Participants will:

Undergo same-day FibroScan assessment to confirm normal liver stiffness and steatosis parameters.

Undergo EUS-guided ATI and SWE measurements of both the right and left hepatic lobes during their clinically indicated diagnostic EUS examination.

Have demographic, clinical, and laboratory information recorded for analysis.

연구 개요

상세 설명

Vibration-controlled transient elastography (FibroScan) with Liver Stiffness Measurement (LSM) and Controlled Attenuation Parameter (CAP) is widely used for the non-invasive assessment of liver fibrosis and steatosis. Although these techniques have demonstrated good diagnostic performance, they have several limitations, including technical failure in obese individuals, reduced accuracy in the presence of ascites or narrow intercostal spaces, and the inability to obtain real-time image-guided measurements from specific areas of the liver.

Endoscopic ultrasound (EUS) provides high-resolution imaging of both hepatic lobes through the stomach and duodenum, allowing quantitative assessment of liver tissue under direct visualization. Recent advances have enabled the integration of Attenuation Imaging (ATI), which quantifies hepatic steatosis, and Shear Wave Elastography (SWE), which measures liver stiffness by estimating tissue elasticity and shear wave velocity, into EUS platforms. These techniques may overcome several limitations of conventional transabdominal elastography and have the potential to provide more reliable liver tissue characterization.

Before EUS-guided ATI and SWE can be evaluated as diagnostic tools for liver disease, normal reference values in individuals without liver disease must be established. Currently, there are limited data regarding normal EUS-guided ATI and SWE measurements, particularly in healthy adults with normal FibroScan findings. Establishing these reference ranges is essential for interpreting future studies involving patients with hepatic steatosis and chronic liver disease.

This prospective, single-center, observational pilot feasibility study aims to establish preliminary reference values for EUS-guided ATI and SWE in adults undergoing diagnostic EUS for non-hepatobiliary indications who have normal FibroScan examinations. A total of 100 participants will be enrolled after confirming normal liver stiffness (LSM <7.5 kPa) and steatosis (CAP <238 dB/m), along with adequate FibroScan quality criteria.

During the clinically indicated EUS examination, quantitative liver assessment will be performed without introducing additional invasive procedures beyond standard EUS. Attenuation Imaging will be obtained from both the right and left hepatic lobes, with five valid measurements acquired per lobe. Shear Wave Elastography will also be performed in both lobes, with ten valid measurements obtained per lobe. Measurements will be accepted only if predefined quality criteria are met, including acceptable correlation coefficients, propagation maps, and reliability indices. Acquisition time, technical success, and measurement reproducibility will also be recorded.

The primary outcome of the study is to establish preliminary reference values for EUS-guided ATI, SWE elasticity (kPa), and SWE velocity (m/s) for both hepatic lobes. Secondary objectives include evaluating the technical feasibility and reliability of EUS-guided quantitative liver assessment, assessing agreement between right and left hepatic lobe measurements, determining correlations between ATI and FibroScan CAP, evaluating correlations between SWE and FibroScan LSM, and documenting acquisition times for both techniques.

The findings from this pilot study will provide foundational reference data for EUS-guided quantitative liver imaging and support the design of larger validation studies investigating the role of EUS-guided ATI and SWE in the diagnosis and monitoring of hepatic steatosis and fibrosis.

연구 유형

관찰

등록 (추정된)

100

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Telangana
      • Hyderabad, Telangana, 인도, 500032
        • AIG Hospitals
        • 연락하다:
        • 수석 연구원:
          • Dr. Sundeep Lakhtakia, MD, DM
        • 부수사관:
          • Dr. Anudeep Katrevula, MD, DM
        • 부수사관:
          • Dr. Jahangeer Basha, MD, DM

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Adults aged 18 years or older undergoing clinically indicated diagnostic endoscopic ultrasound (EUS) for non-hepatobiliary indications at AIG Hospitals will be screened for eligibility. Participants with normal FibroScan findings, defined as a Controlled Attenuation Parameter (CAP) <238 dB/m and Liver Stiffness Measurement (LSM) <7.5 kPa, who meet all eligibility criteria and provide written informed consent will be enrolled in the study.

설명

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Undergoing clinically indicated diagnostic endoscopic ultrasound (EUS).
  • Same-day FibroScan examination available.
  • Controlled Attenuation Parameter (CAP) <238 dB/m.
  • Liver Stiffness Measurement (LSM) <7.5 kPa.
  • At least 10 valid FibroScan measurements.
  • FibroScan interquartile range (IQR)/median ≤30%.
  • Able and willing to provide written informed consent.

Exclusion Criteria:

  • Known chronic liver disease.
  • Hepatitis B or Hepatitis C infection.
  • Significant alcohol consumption.
  • Decompensated cirrhosis.
  • Portal vein thrombosis.
  • Ascites.
  • Focal liver lesion.
  • Previous liver surgery.
  • Pregnancy.
  • Inadequate FibroScan examination.
  • Poor-quality EUS-guided Attenuation Imaging (ATI) or Shear Wave Elastography (SWE) acquisition.
  • Incomplete study data or withdrawal of informed consent.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Normal FibroScan Cohort
Adults aged 18 years or older undergoing clinically indicated diagnostic endoscopic ultrasound (EUS) for non-hepatobiliary indications who have normal FibroScan findings (Controlled Attenuation Parameter [CAP] <238 dB/m and Liver Stiffness Measurement [LSM] <7.5 kPa). Participants will undergo EUS-guided Attenuation Imaging (ATI) and Shear Wave Elastography (SWE) of the right and left hepatic lobes during the same EUS procedure to establish preliminary reference values and assess the feasibility and reliability of these quantitative imaging techniques.
A clinically indicated diagnostic endoscopic ultrasound will be performed according to standard institutional practice. During the examination, the liver will be visualized from the stomach and duodenum to allow quantitative liver assessment.
Attenuation Imaging (ATI) will be performed during the diagnostic EUS to quantitatively assess hepatic steatosis. Five valid ATI measurements will be obtained from both the right and left hepatic lobes under direct EUS visualization. Measurements meeting predefined quality criteria will be used for analysis.
Shear Wave Elastography (SWE) will be performed during the diagnostic EUS to assess liver stiffness. Ten valid measurements will be obtained from both the right and left hepatic lobes. Shear wave velocity (m/s) and tissue elasticity (kPa) will be recorded, and only measurements meeting predefined quality criteria will be included in the analysis.
Participants will undergo same-day FibroScan examination before EUS to confirm normal liver stiffness and steatosis. Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) will be recorded, with at least 10 valid measurements and acceptable quality metrics required for study eligibility.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Reference values for EUS-guided Attenuation Imaging (ATI)
기간: During the index EUS procedure (Day 0)
To establish preliminary reference values for EUS-guided Attenuation Imaging (ATI) in the right and left hepatic lobes of adults with normal FibroScan findings. ATI values will be reported as mean ± standard deviation (SD), median (interquartile range [IQR]), and 95% reference intervals.
During the index EUS procedure (Day 0)
Reference values for EUS-guided Shear Wave Elastography (SWE) elasticity
기간: During the index EUS procedure (Day 0)
To establish preliminary reference values for EUS-guided SWE elasticity (kPa) in the right and left hepatic lobes. Results will be reported as mean ± SD, median (IQR), and 95% reference intervals.
During the index EUS procedure (Day 0)
Reference values for EUS-guided Shear Wave Elastography (SWE) velocity
기간: During the index EUS procedure (Day 0)
To establish preliminary reference values for EUS-guided SWE shear wave velocity (m/s) in the right and left hepatic lobes. Results will be reported as mean ± SD, median (IQR), and 95% reference intervals.
During the index EUS procedure (Day 0)

2차 결과 측정

결과 측정
측정값 설명
기간
Technical success rate
기간: During the index EUS procedure (Day 0)
To determine the proportion of participants in whom acceptable EUS-guided ATI and SWE measurements are successfully acquired according to predefined quality criteria.
During the index EUS procedure (Day 0)
Measurement reliability
기간: During the index EUS procedure (Day 0)
To evaluate the reliability and reproducibility of EUS-guided ATI and SWE measurements using predefined quality parameters.
During the index EUS procedure (Day 0)
Agreement between right and left hepatic lobe measurements
기간: During the index EUS procedure (Day 0)
To assess agreement between ATI and SWE measurements obtained from the right and left hepatic lobes.
During the index EUS procedure (Day 0)
Correlation between ATI and FibroScan CAP
기간: During the index EUS procedure (Day 0)
To evaluate the correlation between EUS-guided ATI measurements and FibroScan Controlled Attenuation Parameter (CAP).
During the index EUS procedure (Day 0)
Correlation between SWE and FibroScan Liver Stiffness Measurement (LSM)
기간: During the index EUS procedure (Day 0)
To evaluate the correlation between EUS-guided SWE measurements and FibroScan Liver Stiffness Measurement (LSM).
During the index EUS procedure (Day 0)
Acquisition time
기간: During the index EUS procedure (Day 0)
To determine the time required to complete EUS-guided ATI and SWE measurements during the diagnostic EUS examination.
During the index EUS procedure (Day 0)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 20일

기본 완료 (추정된)

2027년 8월 30일

연구 완료 (추정된)

2027년 9월 20일

연구 등록 날짜

최초 제출

2026년 7월 15일

QC 기준을 충족하는 최초 제출

2026년 7월 15일

처음 게시됨 (실제)

2026년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 15일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Non-hepatobiliary Indications에 대한 임상 시험

Endoscopic Ultrasound (EUS)에 대한 임상 시험

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